CMS Releases 2015 Medicare Clinical Lab Fee Schedule Update

CMS has posted the 2015 update to the Medicare clinical laboratory fee schedule files

CMS Removes Seven Medicare National Coverage Determinations, Leaving Coverage to MACs

Yesterday CMS posted a Final Decision Memorandum for the Expedited Removal of National Coverage Determinations (NCDs).  By way of background, in an August 7, 2013 Federal Register notice (78 FR 48164), CMS established an expedited process for removing NCDs under certain circumstances, such as when they are no longer contain clinically pertinent or when the items or services are used infrequently by beneficiaries. Removal of an NCD does not necessarily result in noncoverage; instead, it allows the local Medicare Administrative Contractors (MACs) to determine coverage.

CMS reviewed NCDs that have not been reviewed in 10 years in order to evaluate the continued need for those policies to remain active on a national scale, and on November 27, 2013 CMS published for public comment the first list of NCDs proposed for removal. After review of public comments, CMS is now removing the following NCDs from the NCD Manual, effective December 18, 2014:

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CMS Announces Timeline for Next Phase of DMEPOS Competitive Bidding

CMS has announced its detailed timeline for recompeting the supplier contracts awarded under Round 2 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program and the National Mail-Order diabetic testing supplies competition. All current Round 2 and National Mail-Order diabetic testing supplies contracts will be up for rebidding. The current contract period expires on June 30, 2016; the new contracts will begin on July 1, 2016. The first key date in the recompete cycle is December 18, 2014, when supplier registration for bidding opens, and the actual bid window opens on January 22, 2015. The full timeline is as follows (note that dates are subject to change):

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CMS Posts January 2015 Update to Medicare Part B Drug Pricing Files

CMS has posted the January 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the first quarter of 2015. CMS notes that prices for the top Part B drugs decreased by 0.1 % on average this quarter, and prices changed 2% or less for 26 of the top 50 higher-volume drugs.

CMS Delaying Enforcement of Medicare Part D Drug Prescriber Enrollment Requirements

CMS has announced that it is delaying a provision of its 2015 Medicare Advantage/Medicare Part D final rule, published on May 23, 2014, that requires physicians and other eligible professionals who prescribe Part D drugs to be enrolled in Medicare (or have a valid opt-out affidavit on file) for their prescriptions to be covered under Medicare Part D. While the final rule stated that the effective date for this requirement would be June 1, 2015, CMS has announced that it is delaying enforcement of this provision until December 1, 2015. CMS notes that Part D drug prescribers must submit their Medicare enrollment applications or opt-out affidavits to their Medicare Administrative Contractors by June 1, 2015 to provide sufficient processing time and prevent prescription drug claims from being denied beginning December 1, 2015.

CMS Issues Final Medicare Coverage with Evidence Development (CED) Guidance

On November 20, 2014, CMS released its final Medicare coverage document entitled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development.”  CED policy provides the framework for Medicare coverage of items or services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CMS notes that the CED process “can expedite earlier beneficiary access to innovative technology while ensuring that systematic patient safeguards” are in place. The final guidance describes, among other things, the history of CED, its statutory basis, governing principles, requirements for studies under the CED framework, coverage of control groups in CED studies, and transparency of such studies. CMS also responds to public comments received on a draft guidance document published on November 12, 2012. For instance, CMS notes that it has deleted a previous statement that it expects to use CED infrequently, since technology is being presented to the agency for coverage earlier in the technology lifecycle, and requesters more frequently ask CMS to consider using CED for their particular technology. CMS also agrees with commenters that CED should not be used when other forms of coverage are justified, should not duplicate efforts of other agencies or existing medical evidence, and should generally expand access to technologies. CMS also clarified that Medicare Administrative Contractors may use LCDs to determine coverage of items and services to the extent that they do not conflict with national Medicare policy.

CMS Update on Status of Final Medicaid FULs

CMS has announced that while it still has no fixed date for releasing finalized Affordable Care Act (ACA) federal upper limits (FUL) for multiple source prescription drugs, it intends to release the finalized ACA FULs at or about the same time that it publishes a final rule pertaining to Medicaid reimbursement for covered outpatient drugs under the ACA. According to the latest unified agenda, CMS now expects to issue that rulemaking in April 2015. In the interim, CMS will continue to post the draft monthly ACA FUL files.

CMS Releases 2015 Medicare DMEPOS Fee Schedule

CMS has released the Medicare DMEPOS fee schedule files that are effective January 1, 2015.  The DMEPOS fee schedule update factor for 2015 is 1.5%. 

CMS to Expand Nursing Home MDS Focused Surveys

In mid-2014, state survey agencies and CMS piloted a short-term focused survey in five states to assess nursing home Minimum Data Set, Version 3.0 (MDS 3.0) coding practices and its relationship to resident care. According to a CMS memo to state survey agencies, these surveys enhanced surveyors’ ability to identify errors and deficiencies, such as inaccuracies related to staging and documentation of pressure ulcers, the classification of antipsychotic drugs, and coding regarding the use of restraints. CMS therefore announced that it plans to expand these surveys nationwide in 2015. The scope of some or all of the focused surveys also will be expanded to include an assessment of the staffing levels of nursing facilities. Specifically, the assessment is intended to verify the staffing data self-reported by the nursing home and identify changes in staffing levels throughout the year.

CMS Updates Outpatient Therapy Caps for 2015

CMS has announced that the CY 2015 Medicare outpatient therapy limit is $1,940 for physical therapy and speech-language pathology combined and $1,940 for occupational therapy. The therapy cap exceptions process was extended through March 31, 2015 by the Protecting Access to Medicare Act of 2014.

CMS Delaying Enforcement of HIPAA Health Plan Enumeration/Health Plan Identifier Regulations

CMS has announced that it is delaying until further notice enforcement of its regulations pertaining to health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA transactions, which were adopted in a September 5, 2012 final rule. This enforcement delay, which is effective October 31, 2014, applies to all HIPAA covered entities, including healthcare providers, health plans, and healthcare clearinghouses. This enforcement discretion period will allow HHS to consider recent recommendations by the National Committee on Vital and Health Statistics (NCVHS) that covered entities not use the HPID in the HIPAA transactions.

CMS Releases 2015 HCPCS Files

CMS has posted the 2015 update to the alphanumeric HCPCS files.  The files include the Level II alphanumeric HCPCS procedure and modifier codes, their long and short descriptions, and information on Medicare coverage and pricing.

FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

This post was written by Vicki Morris.

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.

The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.

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CMS Launches "Transforming Clinical Practice Initiative"

CMS has announced its newest innovative delivery reform program, called the “Transforming Clinical Practice Initiative,” which will provide up to $840 million over four years to help clinicians share, adapt, and develop quality improvement strategies. CMS intends to make awards for the following two types of systems:

  • Practice Transformation Networks are peer-based learning networks designed to help clinicians develop core competencies specific to practice transformation. CMS is seeking applicants that have pre-existing relationships with multiple clinician practices that include data sharing capabilities (e.g., health systems; regional extension centers; quality improvement organizations; large group practices; regional/state-based health collaboratives; and hospital systems).
  • Support and Alignment Networks will promote workforce development through organizations that use tools such as continuing medical education, maintenance of certification, and core competency development to help ensure sustainability of these efforts. Applicants could include medical professional associations, specialty societies, and organizations that generate evidence-based clinical practice guidelines, support efforts to reduce unnecessary testing and procedures, and effectively incorporate safety and patient/family engagement.

Applicants are encouraged to submit a letter of intent by November 20, 2014, and applications are due by January 6, 2015. CMS anticipates announcing awards in spring/summer 2015.

CMS Announces ACO "Investment Model" Initiative to Support Care Coordination Nationwide

CMS has announced a new Accountable Care Organization “Investment Model” that was developed in response to concerns that some providers lack adequate access to the capital needed to invest in infrastructure necessary to successfully implement population care management. CMS will provide as much as $114 million in upfront investments to up to 75 ACOs across the country to help these ACOs make infrastructure investments and develop new ways to improve care for Medicare beneficiaries.

CMS Solicits Suggestions for Potential PQRS Measures

CMS is inviting quality measure suggestions for potential use in the Physician Quality Reporting System (PQRS) and other physician quality programs. Measure suggestions will be accepted on an ongoing basis, with measures submitted prior to June 15, 2015 eligible to be considered for inclusion in the PQRS as early as 2017.

CMS Releases Medicare Advantage/Drug Plan Quality Data, Enforcement Statistics

CMS has posted the 2015 Medicare Star Ratings for Medicare Advantage (MA) and Medicare Part D prescription drug plans (PDPs). According to a CMS fact sheet, there are increases in the number of Medicare beneficiaries in high-performing MA plans and PDPs for 2015, while CMS notes “dramatic improvement” among plans that had received the low performing icon in 2014. CMS also is interested in receiving information from the public regarding potential data differences in MA and Part D quality measurements for dual-eligible versus non-dual-eligible enrollees. Information is due November 3, 2014. Finally, CMS has released the MA and PDP annual audit and enforcement report for 2013. According to the report, CMS imposed 43 CMPs totaling almost $8.4 million on 39 different organizations and 5 cases of immediate suspension of enrollment and marketing activities for issues identified in 2012 and 2013. Most violations cited in enforcement actions related to inappropriate delays or denials of access to health services and medications for enrollees.

Update on CMS Medicare Appeals Administrative Agreement Offer

As previously reported, CMS is offering an "administrative agreement" providing partial payment to hospitals that drop their appeals related to certain short-stay hospital claims in an effort to reduce the backlog in Medicare appeals. CMS has posted updated “frequently asked questions” on its proposed settlement process. The deadline for applying for the settlement is October 31, 2014, but providers may request an extension if they are not able to meet this deadline.

Update on Sunshine Act "Open Payments" Public Data Review and Data Correction Deadline

CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information.  The tool allows the public to search identified data for physicians, teaching hospitals, or companies.  CMS is also reminding applicable manufacturers and GPOs of an October 31, 2014 deadline for making corrections to any 2013 Open Payments disputed records for publication on or before December 31, 2014 (although data corrections can be performed at any time). Disputes that remain unresolved as of October 31, 2014 will display as disputed in the Open Payments database.

CMS Releases Preliminary Determinations for New 2015 Clinical Laboratory Fee Schedule Codes

CMS has posted its preliminary payment determinations for new 2015 clinical laboratory fee schedule codes. The document lists CMS’s recommendation regarding the basis of payment for codes -- either crosswalk or gap-fill. Note that CMS is recommending to delay pricing various individual drug testing screening codes given “the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for.” Additional information about the comment and reconsideration process is available on the CMS website.

Older Entries

October 8, 2014 — CMS to Revise Five Star Quality Rating System for Nursing Homes

October 8, 2014 — CMS Launches "Open Payments" Public Database; Usability Concerns Remain

October 6, 2014 — RACs Identified $3.75 Billion in Improper FFS Medicare Payments in FY 2013

October 2, 2014 — CMS Seeks Input on Potential Delivery Innovations in Medicare Part D, Medicare Advantage, & Other Programs

September 11, 2014 — CMS Updates Medicare Part B Drug Pricing Files

September 8, 2014 — Medicare Ambulance Update Factor for CY 2015

September 4, 2014 — CMS Offers Settlement to Acute Care Hospitals, CAHs to Resolve Patient Status Denial Appeals

August 28, 2014 — More Changes to Sunshine Act "Open Payments" Timeline

August 21, 2014 — CMS Fingerprint-Based Background Checks are Underway - Impacting "High-Risk" Providers and Suppliers

August 20, 2014 — CMS Revises Sunshine Act "Open Payments" System Review/Dispute Deadlines Amid Concerns about Data Accuracy

August 19, 2014 — CMS Seeks Innovative Models on Beneficiary Engagement and Behavioral Insights

August 12, 2014 — CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

August 12, 2014 — Medicare Intravenous Immune Globulin (IVIG) Demonstration Launched

August 12, 2014 — CMS to Restart RAC Reviews

August 12, 2014 — Sunshine Act "Open Payments" System Off to Rocky Start as Data Discrepancies Force System Off-Line

July 24, 2014 — Revised CMS Policy on Medicare Part D Drugs for Hospice Enrollees

July 24, 2014 — Sunshine Act Open Payments System Review/Dispute Process Underway

July 17, 2014 — CMS Announces Plans for Medicare DMEPOS Competitive Bidding Round 2 Recompete and National Mail-Order Recompete

July 2, 2014 — CMS Proposes Discontinuing 2 HCPCS Codes under New Demonstration

June 25, 2014 — HHS Provides Update on ACA Insurance Costs and Choices, Announces Management Changes

June 25, 2014 — CMS Adds MAC/RAC "Provider Relations Coordinator" for Auditor Process Issues

June 25, 2014 — CMS Plans Medicare Quality "Star" Ratings for Hospitals, Dialysis Facilities, Home Health

June 25, 2014 — CMS Releases Updated Hospital Charge Data, New Chronic Conditions & Geographic Variations Files

June 12, 2014 — CMS Releases July 2014 Medicare Part B Drug ASP Update

June 6, 2014 — Is anybody home? Medicare contractors on the prowl for DMEPOS supplier violations of posted business hours and other physical facility standards.

June 2, 2014 — CMS Abandons Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

June 2, 2014 — CMS Announces New Public Comment Process on Requests to Discontinue HCPCS Codes

June 2, 2014 — HHS Launches Second Round of State Innovation Models Initiative

May 23, 2014 — CMS Extends Partial ICD-9-CM and ICD-10 Code Freeze to Reflect Transition Delay

May 15, 2014 — CMS to Implement Ordering/Referring Denial Edits for HHA Certifying Physicians, Effective July 1, 2014

May 14, 2014 — CMS Announces Reforms to Quality Improvement Organization Program

May 14, 2014 — CMS Extends "Hardship Exemptions" Policy for Health Insurance Purchasers

April 28, 2014 — CMS Announces Changes to Comprehensive End-Stage Renal Disease (ESRD) Care Initiative

April 28, 2014 — CMS Offers Guidance to Hospitals and States Ahead of DSH Compliance Audits

April 28, 2014 — CMS Posts First Medicare Inpatient Psychiatric Facility Quality Data

April 28, 2014 — CMS Issues Call for PQRS Quality Measures

April 16, 2014 — CMS to Implement Fingerprint-Based Background Checks for High-Risk Providers and Suppliers in 2014

April 10, 2014 — Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

April 9, 2014 — CMS Releases Physician-Specific Medicare Charge/Payment Data

April 9, 2014 — CMS Announces Final 2015 Medicare Advantage/Part D Drug Plan Rates and Policies

April 8, 2014 — CMS Seeking Comments on Supervision Levels for Select Hospital Outpatient Services

April 8, 2014 — HHS Releases HIPAA Security Risk Assessment Tool

April 8, 2014 — CMS Extends Deadline for Individuals to Enroll in Health Insurance through Exchanges

March 25, 2014 — CMS Finalizes 2014 Policy on Medicare Payment for Hospice Enrollees' Drug Expenses

March 24, 2014 — CMS Releases Subregulatory Guidance on ACA Insurance Coverage, Exchange Issues

March 20, 2014 — CMS Expands Medicare EHR "Meaningful Use" Hardship Exception to Cover Vendor Issues

March 20, 2014 — Medicare Paper Claims Must Be Submitted on Revised 1500 Form By April 1, 2014

March 20, 2014 — Two-Midnight Inpatient Admissions Policy Guidance

March 19, 2014 — CMS Posts April 2014 Medicare Part B Drug ASP Files

March 18, 2014 — "Medicare Care Choices Model" to Allow Certain Hospice Patients to Seek Curative Care

March 4, 2014 — CMS Announces RAC Audit "Pause," Upcoming RAC Program Reforms

March 4, 2014 — CMS Posts Final HIPAA Administrative Simplification Transaction Testing Checklists

March 4, 2014 — CMS Continues to Modify Implementation of 2-Midnight Inpatient Admissions Policy

March 3, 2014 — CMS Proposes 2015 Payment, Policy Updates for Medicare Advantage and Drug Plans

March 3, 2014 — CMS Invites Suggestions for Advanced Diagnostic Imaging Quality/Safety Regulations

March 3, 2014 — CMS to Allow Retroactive ACA Insurance Subsidies for Certain Non-Marketplace Plans

February 18, 2014 — CMS Issues Draft Guidance for Qualified Health Plan Issuers for 2015

February 13, 2014 — CMS Considering Innovative Episode-Based Payment Models for Outpatient Specialty Practitioner Services

February 13, 2014 — CMS Again Extends "Probe & Educate" Phase for 2-Midnight Inpatient Admissions Criteria Implementation; Clarifies Physician Certification Requirements

February 12, 2014 — CMS Outlines 2013 "Sunshine Act" Open Payments Program Registration/Data Submission Process

January 15, 2014 — CMS Loosens Restrictions on Disclosure of Physician-Specific Medicare Payment Data

January 7, 2014 — CMS Steps Up Efforts Aimed at "Recalcitrant" Medicare Providers and Suppliers

January 7, 2014 — CMS Requests Feedback on ACO Initiatives

January 7, 2014 — CMS Revises Hospital Equipment Maintenance Requirements

January 7, 2014 — Hardship Exemption for Individuals with Cancelled Insurance Policies

January 6, 2014 — CMS Invites Comments on Medicare Payment for Hospice Enrollees' Drug Expenses

December 12, 2013 — CMS Releases 2014 Medicare DMEPOS Fee Schedule

December 10, 2013 — CMS Blog Post Announces Delay in Electronic Health Record (EHR) Incentive Program "Stage 3" Meaningful Use Start

December 10, 2013 — Final 2014 Medicare Clinical Lab Rates Set

December 10, 2013 — 2014 HCPCS Update Posted

December 10, 2013 — Updated Medicare Part B Drug Files Released

December 10, 2013 — CMS Proposes Removing 10 Medicare National Coverage Policies

December 9, 2013 — CMS Announces Plans to Finalize ACA Medicaid Drug Pricing Policy in July 2014

November 25, 2013 — CMS Releases Standard Consumer Notices under ACA Grandfathering/Transitional Policy

November 25, 2013 — CMS Letter to States on Quality Considerations for Medicaid and CHIP Integrated Care Models

November 14, 2013 — CMS Announces Medicare DMEPOS Bidding Round 1 Recompete Contract Suppliers

November 14, 2013 — CMS Guidance on Medicare Inpatient Hospital Admissions Two-Midnight Policy

November 14, 2013 — CMS Launches Virtual Research Data Center

November 14, 2013 — Applications for 2015 HCPCS Codes Due Jan. 3, 2014

November 12, 2013 — CMS "Phase 2" Ordering/Referral Denial Edits to Go Live on Jan. 6, 2014

November 11, 2013 — CMS Announces Inflation Update to "Sunshine Act" Reporting Thresholds for 2014

October 31, 2013 — CMS Expects Delay in Release of 2014 HCPCS Update and Final Coding Decisions

October 30, 2013 — Obama Administration Aligns Health Exchange Enrollment Deadline and "Shared Responsibility" Penalty Trigger

October 30, 2013 — IPPS New Technology Add On Applications for FY 2015 Due November 25

October 10, 2013 — CMS Limits Compliance Reviews under New "2 Midnight" Inpatient Admissions Policy

October 10, 2013 — CMS Posts Revised Gapfill Payments for New Molecular Pathology Codes; Reconsideration Requests Due Oct. 30, 2013

October 9, 2013 — CMS Sets 1% Payment Update for Medicare Ambulance Rates in 2014

October 8, 2013 — HHS OCR Releases HIPAA Privacy Rule Guidance Documents

October 7, 2013 — Medicare Rates to Fall by Average of 37% under DMEPOS Competitive Bidding "Round 1 Recompete" Contracts

September 17, 2013 — CMS Issues Guidance on Admission Order and Certification Requirements for Inpatient Admissions

September 16, 2013 — CMS Releases Fourth Quarter 2013 Drug ASP Files

September 10, 2013 — No CMS DME Face-to-Face Rule Enforcement Before 2014

September 5, 2013 — CMS Seeks Input on Advanced Diagnostic Imaging Program

August 27, 2013 — CMS Updates Off-The-Shelf (OTS) Orthotics Listing for 2014

August 27, 2013 — CMS Call on Draft Electronic Clinical Template for Lower Limb Prostheses (Sept. 11)

August 8, 2013 — CMS Invites Comments on Release of Physician-Specific Payment Data

July 29, 2013 — CMS Announces First Temporary Moratoria on HHA, Ambulance Supplier Enrollment in High-Risk Areas under ACA Authority

July 29, 2013 — In Advance of Sunshine Act Reporting, CMS Releases Physician & Industry Resources

June 28, 2013 — CMS Delays DME Face-to-Face Requirement until Oct. 1, 2013

June 27, 2013 — CMS Releases Data on Medicare Outpatient Hospital Payments